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The Next Generation in Bone Hemostasis

OSTENE is a synthetic, biodissolvable implant material1 that:

  • Provides immediate bone hemostasis2-4
  • Can be used on all bleeding bone surfaces1
  • Is completely biocompatible6
  • Does not require removal2-6—water-soluble polymer dissolves within 48 hours5,7
  • Is a mechanical barrier that does not act biochemically1,2
 

Does NOT increase infection rates*

Comparison of bone healing in a rabbit tibia model5

Comparison of bone healing in a rabbit tibia model

The rabbit tibia model was inoculated with Staphylococcus aureus introduced into the intramedullary canal through a defect created at the anteromedial facet of the proximal tibia.

After 4 weeks, the cross section of rabbit tibia shows normal bone development in the cortical window of the OSTENE and control samples. The bone wax cross section shows signs of osteomyelitis with no sign of bone healing.5 Read more

Twenty-four cortical bone defects inoculated with Staph aureus were either treated with OSTENE, bone wax, or left without a hemostatic agent as the control. Results after 4 weeks showed no difference between the OSTENE group and the control group in the rates of osteomyelitis, positive cultures, or bone healing. In both groups, two defects (25%) developed osteomyelitis. The remaining six defects in each group (75%) exhibited normal bone healing with no evidence of osteomyelitis. However, in the defects treated with bone wax, all defects became infected and developed osteomyelitis. There was no bone healing in any of the defects treated with bone wax.

 

Does NOT interfere with bone healing*

Studies on sternal, cranial, and tibial animal bone healing show OSTENE facilitates normal osteogenesis while negligible healing is shown with bone wax.2-6

Sternal healing evaluation in a rabbit model3

Sternal Healing Evaluation in a Rabbit Model

Mechanical properties of healed sternum at 6 weeks3

Mechanical Properties of Healed Sternum at 6 weeks

After 6 weeks, results showed that the OSTENE-treated sternums healed normally with twice the flexural strength of the sternums treated with bone wax. The group treated with bone wax had fibrous tissue and residual wax interfering with healing. The use of OSTENE in place of bone wax may help reduce the occurrence of sternal nonunion.3 Read more

Sternal bone healing was evaluated in 20 rabbits undergoing median sternotomy, utilizing either OSTENE or bone wax to achieve bone hemostasis. Sternal healing was assessed using radiographic, histology, and mechanical strength testing. Mechanical strength of each sternum was measured using three-point testing with a 0.2 mm/s crosshead speed. Sternums treated with OSTENE had a significantly higher flexural strength (2.53 ± 0.43 vs. 1.29 ± 0.37 megapascal [MPa]; p < 0.001) and Young’s modulus (0.315 ± 0.056 vs 0.146 ± 0.031 MPa; p < 0.001).

Comparison of bone volume and bone formation at 3, 6, and 12 weeks in cranial rat model4

Comparison of Bone Volume and Bone Formation at 3, 6, and 12 weeks in Cranial Rat Model

The graph shows the comparison in bone volume fraction (BV/TV) where negligible healing was shown with bone wax at 3, 6, and 12 weeks. Representative images depict new bone formation at 3 weeks.4 Read more

Cranial bone healing was evaluated using a rat model, where 3-mm noncritical-sized defects made in the calvaria of 30 rats were either filled with OSTENE, bone wax, or left empty as the control. Ten rats were sacrificed after 3, 6, and 12 weeks, and microcomputed tomography was used to access the bone healing, expressed as fractional bone volume. At 3 weeks, there was no evidence of OSTENE observed, and fractional bone volume was significantly greater than the bone wax-treated defects. At 6 and 12 weeks, OSTENE-treated defects continued to show significantly greater healing, while negligible healing was observed with the bone wax. At 6 and 12 weeks, OSTENE-treated defects continued to show significantly greater healing, while negligible healing was observed with the bone wax.

 

Does NOT cause chronic inflammation*

Chronic inflammatory reaction to bone wax in a rabbit model6

Chronic inflammatory reaction to bone wax in a rabbit model

The inflammatory response to bone wax and OSTENE was compared in a rabbit femur defect model. OSTENE was shown to be noninflammatory, with no evidence of an adverse response in the cortical defect site, medullary cavity, or the surrounding tissue at 4 and 8 weeks.6 Read more

Chronic inflammatory reaction to bone wax is shown in a rabbit model at 2 weeks postimplantation. A thick band of fibrous tissue encapsulates the bone wax, penetrated by macrophages, giant cells, and lymphocytes (magnification x200).

 


*As shown in animal studies, actual clinical effects of these results remain unknown.

 

References

  1. Ostene Bone Hemostasis Material [instructions for use]. Los Angeles, Calif: Ceremed Inc.PN-26 CF607 Rev. H 2011.
  2. Armstrong JK, Han B, Kuwahara K, et al. The effect of three hemostatic agents on early bone healing in an animal model. BMC Surg. 2010;10:37.
  3. Wellisz T, Armstrong JK, Cambridge J, et al. The effects of a soluble polymer and bone wax on sternal healing in an animal model. Ann Thorac Surg. 2008;85:1776-80.
  4. Magyar CE, Aghaloo TL, Atti E, Tetradis S. Ostene, a new alkylene oxide copolymer bone hemostatic material, does not inhibit bone healing. Neurosurgery. 2008;63:373-8; discussion 378.
  5. Wellisz T, An YH, Wen X, et al. Infection rates and healing using bone wax and a soluble polymer material. Clin Orthop Relat Res. 2008;466:481-6.
  6. Wellisz T, Armstrong JK, Cambridge J, Fisher TC. Ostene, a new water-soluble bone hemostasis agent. J Craniofac Surg. 2006;17:420-5.
  7. Singh-Joy SD, McLain VC. Cosmetic Ingredient Review, Washington, DC 20036, USA. Safety assessment of poloxamers 101, 105, 108, 122, 123, 124, 181, 182, 183, 184, 185, 188, 212, 215, 217, 231, 234, 235, 237, 238, 282, 284, 288, 331, 333, 334, 335, 338, 401, 402, 403, and 407, poloxamer 105 benzoate, and poloxamer 182 dibenzoate as used in cosmetics. Int J Toxicol. 2008;27 Suppl 2:93-128.